1. Field of the Invention
This invention relates to skin and hair treatment admixtures and compositions having the capacity to promote protection and healing of skin surfaces and the healthy growth of hair on skin surfaces.
2. Background of the Invention
Researchers in the prior art have indicated at least for the last several years that fish oils have been contain certain components, including vitamins A and D and others not clearly identified themselves, which can significantly reduce blood clotting, and make platelets formed internally less likely to stick together to themselves and to blood vessels in the body; thereby lessening the chance of heart attack due to coronary artery clot. It has also been indicated that fish oil might also prevent hardening of the arteries, in that it appeared to indicate in testing that it might be more effective than polyunsaturated vegetable oils in lowering triglyceride levels in the blood. Researchers have speculated that this was why Eskimos and the Japanese, whose diets have been found to include very large amounts of fatty fish, have often been found to have a lower incidence of cardiovascular disease. What has often been expressed in the prior art as being uncertain, is whether fish oil by itself provided all the health benefits of fish, or whether other elements in the fish, or the human ingesting the fish or its oil (fatty acid) component, worked in some combination to bring about positive health benefits.
One such specific study of the health of Eskimos in Greenland, who consume large amounts of fat yet have extremely low death rates from heart disease, indicated that at least one reason for such general health reports was the fact that the Eskimo diet included consumption of large amounts of fish of several diverse species which were rich in omega-3 fatty acids. It was found in this study that if large amounts of fish were consumed for a long period, that the fish oils appeared to thin the blood, lower cholesterol, reduce inflammatory reactions, lessen the risk of arteriosclerosis and protect against colon cancer.
Cod have been found to be one of the most important food fishes for human beings. These fish live in the northern waters of the Atlantic and Pacific oceans. They produce eggs in the depth of the ocean in the late winter and early spring. The eggs of most species of cod fish rise to the surface to become part of the plankton, the mass of small, drifting plant and animal life of the sea. Mature cod eat small fish, squid and shellfish (crabs and shrimp). Atlantic cod have been found to eat almost anything else it finds, including rocks and shells. The physiology of the Cod's gastrointestinal system reveals that powerful juices in the stomach of the fish digest food or sea life that may be growing on an object; the cod then expel what is found to be undigestible. The Cod's diverse and mysterious diet and digestive system have raised many questions as to possible values of cod-liver oil.
This substance is a yellow, fishy smelling oil obtained from the livers of codfish. The liver in cod functions somewhat similar to the human organ, its manifold functions including the storage and filtration of blood, secretion of bile for digestion, excretion of diverse substances formed elsewhere in the organism and numerous metabolic functions. Cod-liver oil has been found to contain large amounts of vitamins A and D, and at one time many people ingested this oil to protect against vitamin A and D deficiencies. However, over the last number of years, cod-liver oil itself has been found to be rarely used, or, when so used, to be taken in the form of capsules, which have been found to possibly limit the positive effects of this oil. Therefore, the question has been raised, as to how to package deliver, or combine this valuable oil in such a way as to deliver older as well as newly-discovered, possible benefits to humans and other animals.
Additionally of the many benefits, some of which may be yet undiscovered, which are attributed to vitamins A and D, each of which is found in cod-liver oil; it has been noted that:
Vitamin A (retinol): helps maintain skin, eyes, urinary tract; and lining of the nervous, respiratory and digestive systems; and is needed for healthy bones and teeth; and that PA1 Vitamin D: is essential for calcium and phosphorous metabolism; that it helps prevent `rickets` in humans, that the D.sub.3 form occurs in the tissues of animals including humans, and is called the `sunshine vitamin` because it forms in the skin when the body is exposed to sunlight; and is converted by the body into an active form which is unique in functioning not only as a vitamin, but as a "chemical messenger" or "hormone". PA1 (a) None of the prior art substances utilize a nucleophilic reaction between Iodide ions supplied from an Iodine/Povidone-Iodine complex, and a Cod Liver Oil--organic compound, which is activated and catalyzed by a photon component from sunlight and hastened by dilution and supply components comprising mineral oil/water and Red Iodine/Povidone-Iodine components to dilute the Iodine components and provide free iodide ions to thereby substitute these ions for alkyl functional groups on the Cod Liver Oil compound; to produce a final processed iodinated cod liver oil product in a matrix having at least binary fluid phase levels; which, then, upon being mixed together, provide further synergistic properties facilitating stronger healing and treatment properties prior to and upon topical or systemic application. PA1 (b) The prior art substances do not have the substantial capacity to be adequately utilized to promote healing of skin disorders, infections, insults and wounds together with promoting the healthy revitalization and growth of hair, hair follicles and fingernails: or to consistently have the capacity to reach epidermal, subdermal, dermal, duct and nerve root regions associated with skin and mucosal cell and tissue regions. PA1 (c) The prior art substances are not designed to promote adequate temperature stability on skin and mucosal surfaces while providing protection against UV radiation, light rays and promoting even, consistent, noninflammatory, non-peeling suntan thereon. PA1 (d) The prior art substances are additionally not designed to concurrently provide protection against insect and arthropod infestation while also promoting the healing of bites, stings and infection created by components of associated sting elements, and head/appendage elements left inserted in layers of human and animal skin tissue. PA1 (e) It is a further disadvantage of the prior art substances that most all are moderately to substantially toxic if orally ingested or administered in substantial doses topically on the skin surface or by absorption or ingestion to deeper layers of the skin or mucosal surfaces. PA1 (f) It is a further disadvantage, that prior art substances cannot be concurrently administered in therapeutic doses to mucosal, sublingual, subpharyngeal, bronchial and other areas of the oral cavity, throat, trachea and esophagus, or to areas of the anus, bowel, genitals, auditory canal or sinus areas. PA1 (g) A further disadvantage of prior art inventions is their substantial inability to consistently work well, or work at all, in association with, or when used concurrently with, other oral, internal or topical healing or antimicrobial agents administered to animals and humans. PA1 (h) Prior art substances also fail to consistently or adequately, concurrently promote soft, healthy skin surfaces while significantly helping to remove signs of aging wrinkles, warts, blemishes or other insults or irregular growth patterns of the surfaces of skin and mucosal tissue, as the present invention does. PA1 (i) Prior art substances also fail to provide concurrent relief for muscle, joint and spinal pain and tension, and circulatory problems in these regions. PA1 (j) Yet a further disadvantage is the lack of the substantial, or concurrent capacity to clean and provide protection associated with good health to animate and in animate surfaces, or fomites, as the present invention does.
Additionally, it has been found that vitamin A can aid in treatment of many eye disorders (including prevention of night blindness and formation of visual purple in the eye), in helping form and maintain healthy mucous membranes (as well as healthy skin and hair), in building resistance to respiratory infections, and in treating acne, impetigo, boils, carbuncles, and open ulcers when applied externally. Questions have also been raised and some evidence suggested that other benefits of vitamin A could include controlling glaucoma, buffering against cancer, guarding as a part of a bodily, internal defense mechanism against effects of smog and pollution or other environmental toxicity, cushioning against stress, enhancing and speeding healing, helping in removing age spots, fighting infections, fighting skin diseases and shortening the duration of some illnesses.
Vitamin A has also been found to be essential for normal function of the retina, in combining with red pigment of retina (opsin) to form rhodopsin (necessary for sight in partial darkness), in acting as a co-factor in enzyme systems; and (as in part indicated earlier) its necessity for growth of bone, testicular functions, ovarian function, embryonic development, regulation of growth and differentiation of tissues.
It has, therefore, become an important concern to find new and better ways and systems for better delivery and enhancement of vitamins A and D in the body, utilizing its discovered benefits more effectively and finding new uses and benefits for these vitamins and related delivery means or substances carrying these vitamins, for use in the body and on skin and mucosal surfaces.
Additionally, it has been found that aging reduces the skin's ability to synthesize vitamin D, the elderly tend to go in the sun less (losing this potential source of vitamin D activation), and they absorb less of the vitamin D they consume. As indicated in part earlier, vitamin D deficiency can lead to poor calcium absorption and increased bone loss, and some studies have suggested that 30-40% of elderly people who sustain hip fractures or bad recurrent bruising are deficient in vitamin D. The adequate intake of this vitamin has been linked in having at least a modest effect in lowering the risk of colon cancer, and possibly cancers of the prostate and breast. This, also, emphasizes the importance of developing better delivery means for these vitamins, to obtain the benefits of vitamins A and D, and other valuable components of cod liver oil.
Iodine (I) has been used in medicine over the years as an external, and/or topical antiseptic, both as the free element and in the compound iodoform (HI.sub.3).
Iodine is not an abundant element, but has been found to be widely distributed in nature, its salts being found in rocks, soils, seawater and animal and plant tissue. Iodine salts have also, importantly, been found in relatively high concentrations in cod liver oil.
Iodine has been found to be needed in the human body, and deficiency of this element leads to the disease known as `goiter` (swelling in the neck). As a normal constituent of blood plasma, protein-bound Iodine has a concentration of from about 3.5 to about 8.0 mg/dl.
As indicated in part, iodides are valuable medicines. For example, the antiseptic, tincture of iodine, is a solution of iodine in alcohol.
Iodine has been found to be part of a substance called thyroxine, a hormone produced by the thyroid gland which controls the body's rate of physical and mental development.
It has been found to dissolve only slightly in pure water, but to dissolve more easily if the water contains an iodide, or salt of iodine. The iodide and iodine combine to form polyiodides, which are able to dissolve.
Since the mid-1800's, iodine compounds have been used for what has been found to be their antibacterial properties, possessing a broad spectrum of activity against vegetative and sporulated bacteria, fungi, viruses, protozoa and yeast organisms.
Organic iodine products have been made available as alcohol tinctures or aqueous solutions with molecular iodine in concentrations of 2% to 7%. These iodine substances have been found to stain tissues and have a characteristic odor. Additionally, these substances have been found to be irritating and to potentiate infection if used at stock concentrations. It had previously, therefore, in the art been found that only dilute concentrations of 0.1% to 1% aqueous iodine were acceptable for use on exposed tissues.
Iodophors have been known in the art as products in which iodine were complexed with surfactants or polymers. Povidone-iodine (PVP-I) has been found to be a water-soluble, strongly acidic (pH 3.2) iodophor produced by combining molecular iodine with polyvinylpyrrolidone. Iodophors have been found to be essentially odorless, with less staining being associated with its use. Most commercial povidone-iodine products contain 90% water, 8.5% polyvinylpyrrolidone and only 1% iodine. An iodine has been found in this substance to be complexed to polyvinylpyrroli-done by a loose ionic bond, with an equilibrium being found to exist between povidone-bound iodine and free iodine, thus resulting in a constant release of free iodine until the iodine is depleted. It has been postulated in the art that this might account for povidone-iodine's residual effect of some 4 to 8 hours, as the presence of free iodine (I.sub.2) had been found in the art to be directly responsible for the bactericidal effects of iodinated products, the rapidity of bacterial destruction being found proportional to the concentration of free iodine.
Polyvinylpyrrolidone has been found to be a high-molecular weight flexible polymer, having no inherent antibacterial activity itself. It has been said to have an affinity for cell membranes and aid in efficient delivery of free iodine directly to the active site.
Previous studies combined with in vitro data have recommended operational ranges of only 0.1% to 1% PVP-I as a wound lavage solution in that previous to the present invention PVP-I had been associated with some toxicity owing to it acidic pH level and the systemic absorption of iodine. These effects were previously found to be most pronounced when large wounds, body cavities or mucosal surfaces were irrigated.
Additionally, polyhydroxydine is another iodophor found to exist in the art, similar to PVP-I, reported to have antibacterial activity and the ability to enhance wound healing.
Povidone-iodine (PVP-I) is known in the art as a complex which is produced by reacting iodine with the polymer povidone, which as been found, when so complexed, to slowly release iodine. PVP-I occurs in the art as a yellowish brown, amorphous powder in its original reaction composition state; and has been known generally in the art as being used as a topical anti-infective.
When PVP-I is able to be delivered in an acceptable, non-allergic, non-injurious form to an area needing treatment in the body, it is known in the art that this compound, perhaps more than any other antiseptic preparation, is capable of killing all classes of pathogens encountered in various types of infections including gram-positive and gram-negative bacteria (including antibiotic resistant strains and mycobacteria), fungi/yeasts, viruses and protozoa. PVP-I is one of the few microbicides having such a broad spectrum of activity. It has been found that most bacteria are killed in 15 to 30 seconds of application of PVP-I in vitro. It has also been found that microbicidal activity is retained, to some extent in the absence of other conditions or variables such as less effective delivery means; but only in the presence of moderate quantities of blood, pus, mucosal secretions and soap and water, in vitro.
One source of povidone-iodine known in the art, among others, is BETADINE.RTM.. "BETADINE".RTM. is a trademark for preparations of povidone-iodine, produced and manufactured by The Purdue Frederick Company of Norwalk, Conn. which is used in relation to some 23 microbicide-product forms. The BETADINE.RTM. mark is used in association with microbicide aerosol spray, antiseptic gauze, antiseptic lubricating gel, first-aid cream, vaginal health aids, microbicide ointments, mouthwash/gargle products, perianal health aids, skin cleansers, shampoo products, surgical and antiseptic scrub swab aids and swab sticks, sponge brush products, viscous formula antiseptic gauze pads and whirlpool concentrates among other products.
Some of the warnings appearing in association with BETADINE.RTM. products referenced above, which are relevant in consideration of the prior art is that these products are contraindicated for internal use or use in the eyes. Additionally, although some BETADINE.RTM. products can be used in association with mucosal surfaces such as vaginal suppositories or in douche applications, it is warned that only limited use should be made of products for these purposes and that such use can be associated with severe irritation and allergic reaction, and pelvic inflammatory disease, a serious infection of the reproductive system. Also, these products are contraindicated and should not be used for application in or treatment of ears, mouth, face or head; with regard to which injury has occurred during such use. Therefore, the development of a product or composition which can effectively complex and deliver Iodine or povidone-iodine compound in a form more acceptable and non-injurious to the referenced internal, eye, ear, face and head areas, and further provision of better treatment and health benefits to these areas has continued in the art to be a long-standing need. An improved delivery system, such as the present composition for complexing delivering components known respectively to be microbicidal and/or health-enhancing, will supply and deliver such components in a physiologically and immunologically acceptable and preferable form such that respective components will provide their known positive health effects and interface with each other to concentrate and improve these positive health effects.
Mineral oil is a clear, colorless, oily liquid with almost no taste or color. It has been used in the past in medicinal and cosmetic preparations such as laxatives and hair tonics. It has also been used as a diluent or dissolver in the manufacture of plastics, and as a lubricant in industrial operations.
Lipids are one of a large group of oily or fatty substances which have been found to be essential for good health. Lipids, carbohydrates and proteins are the classes of compounds present in all living things. Lipids vary more in composition than any other family of biological compounds. It has been set forth that the only feature that is common to all lipids is their poor solubility in water. As waxes, lipids have been found as coatings on leaves and the feathers of birds. In the body lipids have been found to be used for energy, insulation and protection of inner organs. Additionally, lipids have been found in many cell membranes, including the brain and nerves. The fat-soluble vitamins A and D, vitamins E and K, certain hormones and cholesterol (asteroid) have been found to be lipids. Foods which have been found to be rich in lipids have included egg yolks, liver and embryos of grains and other cereals.
Many kinds of organisms store food in lipid form. In animals including humans, it has been found that the bone marrow, tissues beneath the skin and in the intestines, and tissue surrounding body organs in animals consist mostly of stored lipids. Lipids are vital to animals and plants in many ways, constituting a concentrated source of food energy, yielding twice as many calories as an equal weight of protein or carbohydrate.
Certain lipids have been found to form an essential part of the membranes that enclose and protect every living cell; and similar membranes have been found to surround all intracellular components or bodies within the cell so that each such cell body can do its job (such as mitochondria in metabolism and production of energy), without unwanted interference from other cell bodies (such as rough endoplasmic reticulum in synthesizing protein). Lipids have also been found to be valuable as solvents or dissolving substances for vitamins A, D, E and K, which do not dissolve in water.
Steroids as lipids make up an important part of living things. Many animal hormones (as earlier mentioned in part), including the sex hormones and those produced by the cortex or outer part of the adrenal glands, are steroids, in addition to cholesterol found in the membranes of animal cells.
The presence of lipids in the present invention in the form of iodinated cod liver oil, complexed in an aqueous iodine/PVP-I, mineral oil-fatty acid delivery system provide an improved affinity for cell membranes and aid in efficient delivery of free iodine, and vitamins A and D, directly to the targeted treatment area. This, therefore, helps to solve a number of problems that have existed in the art.
In the past it has been found by researchers that when light or other electromagnetic waves strike matter, it behaves as if it were individual particles of energy instead of continuous waves These particles were named "photons" or "quanta", and were found to travel at the speed of light. This idea of photons was considered essential to the quantum theory in physics, originally resulting from experiments conducted by Max Planck in 1900 showing that a photon's energy was proportional to the frequency of its light.
An electromagnetic force has been defined in the art as acting between all particles carrying an electric charge, and is seen in action in all the phenomena of electricity and magnetism, in light and in radio waves. It is known to control the motions of the negative electrons around the positive-nucleus of the atom and is thus the source of all atomic behavior. Electromagnetic force is attractive between oppositely charged particles, pulling them together, and repulsive between similarly charged particles, pushing them apart. This effect has been found to be proportional to the product of the two charges involved and it stretches out from a charge to infinity decreasing as the inverse square of the distance from the charge in a similar way to the gravitational force.
The manner in which the electromagnetic force has been found to act is described in a theory known as quantum electrodynamics, abbreviated in the art as QED, which sets forth that each particle is surrounded by a cloud of photons, the packets of energy without mass such as are present in light. The particle is seen as constantly lobbing out these photons and then catching them again. If a photon meets another particle, an interaction takes place (such as a pulling together if the particles are oppositely charged); and via the photon a particle passes a message to the other particle. A photon cloud has been found under current theory to be the most dense near the particle, and becoming more thin, or thinning when moving out from the particle to infinity. This explains in the art how the strength of the electromagnetic interaction falls off with distance.
Quantum electrodynamics has proven to be a highly successful theory in the art. It has been found subject to testing because, if charged particles have a photon cloud, this will slightly modify their properties. These slight changes have been measured and found to agree with the predictions of QED theory to an accuracy of a few parts in a million, according to the Encyclopedia of Science and Inventions, "Particle Physics", H. S. Suttman, Inc., Copyright, 1983. The QED theory was developed in the art originally to explain a comparatively small range of occurring phenomena, but has been found to work perfectly in predicting the effect of the electromagnetic force, whether it involves distances as small as a thousandth of a millionth of a millionth of a centimeter, as for that deep inside a charged particle, or out to distances as large as a million miles.
Among the many applications of QED in the art, it has been found that exposure to a photon component can assist in breaking down a compound or diatomic molecule to the free form of a desired substance, and in providing a source of energy to assist in affecting molecular attraction so as to change the properties of or chemically change, a compound or mixture.
One vivid example of this in the art is the photochemistry of photosynthesis, initiated by the excitation of chlorophyll by light, and the chemical synthesis of carbohydrates (sugars, starches and cellulose) performed in the cells of plants, the necessary energy being supplied by sunlight.
Photosynthesis is the most important natural photochemical reaction. Chemical changes due to radiation of light photons are also basic to photography, and high-energy radiation is additionally able to initiate cross-linking of polymers and synthesis of alkyl halides (gamma radiation). Degradation reactions; the breakdown of complex organic structures to simpler compounds by the influence of bacteria, accelerated by oxygen and sunlight; also, therefore, occur as a result of the ionizing effect of short-wave radiation. Ultraviolet radiation catalyzes the formation of photochemical smog from nitrogen oxides and hydrocarbon air contaminants; and has also been found in the art to initiate photolytic decomposition of ketene and accelerate formation of vitamin D in milk.
In a publication entitled "Sunlight, Ultraviolet Radiation and the Skin", from the National Institutes of Health Consensus Development Conference Statement, Vol. 7, No. 8, May 8-10, 1989; it sets forth, among a number of other findings on this subject, that the exposure of living skin tissue to ultraviolet B sunlight (UVB: 290 to 320 nm. on wavelength spectrum) is essential for the endogenous production of Vitamin D.sub.3. This relationship of sunshine to vitamin D.sub.3, as indicated in part earlier herein, and the normal growth and development of the skeleton are well known in the art. It is also reported that exposure of skin to ultraviolet radiation through sunlight (UVR), in the region of 290 to 315 nm. is essential for the formation of vitamin D.sub.3 in the epidermis of skin tissue. It is also noted that numerous systemic medications may augment UVR susceptibility; and it has been found that increased UVR damage may occur with the use of oral antibiotics, antihypertensives, psoralens, immunosuppressive agents, nonsteroidal anti-inflammatory drugs and many other agents. Additionally, it has been found in the art that a wide range and number of topical medications and industrial chemicals may increase the susceptibility of damage to the skin by sunlight. Some of these medications and chemicals include topical psoralens, tretinoin, and other photosensitizing and depigmenting agents.
Ultraviolet radiation in sunlight has been found to be critical for vitamin D synthesis in the skin, as indicated. However, UVR has also been found to produce a wide variety of pathologic effects, including sunburn, pigmentary change, immunologic alterations, and neoplasia. A noted collection or gathering of structural alterations, histological changes, of the epidermis, the dermal-epidermal junction, and the dermis of integumentary tissues has been found to be characteristic in diagnosis of photo damage.
These finds, therefore, indicate the need in the art of a topical composition which will heal skin tissue and promote protection from ultraviolet radiation from the sun while augmenting the valuable health benefits provided by the sun in vitamin D.sub.3 activation and formation in epidermal layers of the skin.
Various types of cosmetic hair growth compositions or topical skin compositions have been known in the art. Typical of these inventions are U.S. Pat. Nos. 5,211,942; 5,183,817; 5,137,718; 5,041,439; 5,032,382; 4,978,527; 4,954,341; 4,912,111; 4,584,192; 4,401,651 and 4,393,043; issued respectively to Deppert, Bazzano, Gillespie, Kasting, Grollier, Brink, Nakamura, Sank, Dell, Knutson and Koulbanis. Copies of the patents cited were enclosed with the parent application pursuant to 37 CFR .sctn..sctn.1.97-1.99.
The Gillespie '718 patent reference discloses a topical antimicrobial cream, essentially comprising a povidone-iodine complex and hydroxyethyl cellulose component, a water soluble emollient such as glycerin, a water soluble surfactant such as nonyphenoxy-polyethanol such as IGEPAL CO-660, and water to form a homogenious solution having a gel-like consistency and clearly not resulting in, or functioning as a system having, stratification into separate co-existing layers.
The Kasting '439 reference discloses a topical hair-growth composition comprising a defined hydroxy imunopyrimidine compound, a solvent such as water or ethanol and a penetration-enhancing carrier consisting of a polar solvent such as 1,2-propanediol is defined combination and ratio with a polar lipid compound which is isocetyl alcohol.
The Grollier '382 reference discloses a light-stable screening cosmetic composition for protecting the skin from UV radiation, comprising a defined weight of bixin compound and a weight percentage of lipid-soluble screening agents including 3-benzylidene-dl-camphor and benzophenome derivatives in a cosmetic vehicle having a fatty phase component. Bixin utilized therein takes the form of an oily extract of annatto containing 0.1% by weight of bixin.
The Brink '527 patent reference discloses a dermatological film-forming emulsion having a film-forming coploymer phase having three monomers, where the first monamer is a monomeric acrylic or methacrylic acid ester of an alkyl alcohol containing a single hydroxyl, the second monamer is a further defined monmeric methacrylic acid ester of an alkyl alcohol, and the third monamer is an N-vinyl lactam and a monamer containing a polyether functionality. The Brink emulsion further comprises a defined percentage of iodine based on total emulsion weight, an emulsifying agent, and a defined percentage by weight of water.
The Nakamura '341 reference is perhaps an example of what appears to be a number of references in the art utilizing an ammonium salt in a hair cosmetic composition. The Nakamura composition comprises a defined percentage by weight of at least one tailored quaternary ammonium salt, in combination by weight and ratio to a defined phosphate.
The Sank '111 reference discloses the use of Minoxidil for wound healing, and the Bazzano '817 patent reference discloses combinations of Retinoids such as Vitamin A acid and Minoxidil-type compounds for hair growth.
The Dell '192 reference discloses a film-forming skin composition comprising three monomers, where the first monomer is an alkyl alcohol containing a single hydroxyl, selected from a group consisting of n-butyl acrylate, isoocytl acrylate and lauryl methylacrylate, the second nomamer is a methacrylic acid ester of an alkyl alcohol such as methanol, ethanol or 1-propanol, selected from a group including methyl methacrylate and n-butyl methacrylate; and the third monamer is an N-vinyl lactam such as N-vinylpyrrolidone, for complexing iodine. The composition further includes an amount of an antimicrobial agent such as iodine of 0.1 to 15% by weight of the copolymer composition.
The Knutson '651 patent reference discloses a wound-healing skin composition containing povidone-iodine, comprising an antimicrobial ointment constituting an admixture of 20 parts by weight of ordinary granulated sugar, 5 parts by weight Betadine.RTM. ointment and 2 parts by weight of Betadine.RTM. solution.
The Deppert '942 reference discloses in its summary in the Official Gazette, Halide Containing Quaternary Ammonium Salts as hair conditioning agents.
The Koulbanis '043 reference discloses a cosmetic composition containing a solution of 0.5 to 20% by weight essential fatty acid such as Vitamin F and jojoba oil and arachidonic acid.
Additionally, the Chaussee, N'Guyen and DuBois patent references have been brought to the applicant's attention.
Though it appears that some use of mineral oil, cod liver oil and povidone-iodine are taught in Chaussee as alternative use substances; there proportions, method of entering the substance and ultimate delivery means in combination with other substances is substantially different than as set forth in the present inventive composition. Additionally, Chaussee does not specifically tie in whatever means employed to make that substance, to its final product, as done in the present invention. One skilled in the art could pursue a number of different processes to arrive at Chaussee's final product; whereas in the present invention, the novel process of making the product and the product composition itself are each novelly and specifically tied to one another. No other process of making the present invention is acceptable or consistent with the teaching of the present hair and skin composition. In the present invention, both the process and the final product composition are distinguishable from, and not obvious in view of, Chaussee.
It would appear that the N'Guyen patent reference discloses and claims a cosmetic composition comprising what it terms a cosmetically acceptable fatty body, an antioxidant system containing very different substances from the present invention; including tocopherol, caffeic acid, an ascorbyl ester of an aliphatic acid, a complexing agent such as ethylenediamine tetracetic acid or citric acid and a thiol such as N-acetyl cysteine. The "acceptable fatty body", as set forth in N'Guyen, can be a food composition such as edible oils or margarine; and the cosmetic composition of N'Guyen can be in the form of a cream for the purpose of protecting against oxidation of skin lipids. However, the complexing or delivery system by which N'Guyen's margarine is introduced, together with the method of introducing substances, appears materially different; with no suggestion being found in N'Guyen's disclosure that mineral oil, cod liver oil, povidone-iodine or other components including other iodine complexes or photon light component can be utilized as in the case of the present invention to produce an iodinated cod liver oil complex in a matrix comprising a plurality of fluid phase levels which then may be recombined synergistically prior to therapeutic application; or with regard to the disclosed uses of the present invention.
It would appear that one object of the DuBois teaching is to provide a cosmetic product for skin care containing natural emollients used in association with paraffin hydrocarbons (i.e., saturated hydrocarbons of the formula C.sub.n H.sub.2n +2, i e., "alcanes") and lecithin. However, DuBois discloses and claims an emulsion in aqueous phase consisting specifically of water and an extract of hydro-dispersible lecithin enriched in phosphatidylcholine in a proportion between 0.01% and 5% of the weight of the water and an oil phase consisting of paraffin hydrocarbons that are oily or solid and liposoluble lecithin, with the oily phase constituting between 5% to 90% by weight of the whole. There appears to be no suggestion in the DuBois teaching, that an oil phase be complexed with other ingredients found in the present invention and be processed by any method (especially involving photo reaction) akin or related to what is disclosed in the present invention with regard to binary or tertiary phase processes involving the important photon component and process of nucleophilic substitution of cod liver oil organic compound, and production, which takes place as a result thereof to produce the composition of the present invention.
It is therefore submitted that one skilled in the cosmetic art or that of hair treatment or the healing of skin problems, would not be motivated to combine the Chaussee, N'Guyen or DuBois references, or any of the other references found in the prior art, to achieve the present invention. Even, if it were assumed, that the three skin care emulsions or compositions disclosed or taught in Chaussee, N'Guyen and DuBois suggested a possible combination of their components, which they do not, one still would not have the teachings of the present invention.
None of the references specifically illustrate or teach the present invention. Nor is the present invention obvious in view of any of the prior art references listed herein. The chemical components and relationships there-between are significantly different in the present invention, as is the specific tied in process of the invention of combining the present components novelly to produce the final product composition of the invention. Additionally, concurrent phase level relationships, which function in relationship to one another in the final product are not present in the relevant prior art. All of the prior art heretofore known suffer from a number of important disadvantages:
One of the central objects of the processed product of the present invention is to provide a productive complex of admixed components which will both, provide a vehicle for and enable efficient and timely iodination by nucleophilic substitution of alkyl functional groups on a cod liver oil component, and provide a transfer complex through remixing of the product's fluid levels prior to application, to allow synergistic reassociation of the fluid levels, enhancing the properties and effects of each of its product reaction components, and their ability to be delivered to, and reach targeted treatment areas.
Another principal object of the invention is to provide a processed product which is produced by utilizing a nucleophilic reaction between Iodide ions, diluted from and supplied by an Iodine/Povidone Iodine complex, and Cod Liver Oil; energetically activated by natural sunlight or substantially equivalent artificial light, and photo-reaction with Cod Liver Oil; and assisted and hastened in the dilution of iodide ions by fluid-dilution means comprising mineral oil and water; to produce a processed product with a plurality of fluid stage levels comprising respective reaction product components; which, after sun or a light exposure, are remixed to provide enhanced and synergistic chemical property effects to one another and provide a more effective transfer medium or complex for delivering components of the processed product to skin and hair areas targeted for treatment.
A further object of the present invention is to provide a specifically and critically linked product by process comprising the presence of lipids in the form of iodinated cod liver oil, complexed in an aqueous Iodine/PVP-I, mineral oil-fatty acid delivery system to provide an improved affinity for cell membranes (also containing lipids), and aid in the efficient and more timely delivery of free iodine, vitamins A and D, and other health benefits of cod liver oil, directly to the targeted treatment areas, both internally and externally in humans and animals, thus improving means of delivery to these areas and solving associated long-term needs in the prior art.
Another, object of the present invention is to provide a consistently effective, therapeutic composition system which is concurrently effective, by varying mode of delivery and therapeutic doses, in facilitating healing of a diverse range of skin and mucosal problems, disorders, abnormal growth and infections while promoting productive growth of hair or fur; promoting nontoxic, noninflammatory, topical fluid temperature stability on skin surfaces while protecting against damaging ultraviolet rays and facilitating consistent overall, attractive, non-peeling suntan development; and repelling from skin, hair and fur surfaces many diverse species of arthropods and insects while facilitating healing of their prior damaging effects, including expulsion of attached or embedded insect/arthropod bite, attachment or sting elements, and healing of their associated wounds or infection.
An additional object of the present invention is to provide a mixable binary or ternary fluid composition system which is cost-effective in preparing, which has the capacity as a topically or internally administered medicine to reach and affect deeper layers of skin tissue, mucosal tissue and tissue associated with various body orifices, including nerve endings, in a substantially nontoxic manner, and to be easily utilized with other forms of therapeutic treatment and medicine regarding these tissues, associated component cells and surfaces, in both human and veterinary medical applications.
It is yet a further object of the present invention to provide a binary and tertiary fluid composition system where the individual layers when mixed and applied act to facilitate one another functionally in softening and cleansing skin surfaces; and relieving muscle, joint and spinal oriented pain, tension and circulatory problems, while having the concurrent capacity to provide microbialcidal and microbialstatic protection to both animate and inanimate surfaces.